通用型静脉注射氨磺必利（QLG2069）用于预防成人术后恶心和呕吐：一项III期、多中心、随机、安慰剂对照研究。

Generic Intravenous Amisulpride (QLG2069) for the Prevention of Postoperative Nausea and Vomiting in Adults: A Phase III, Multicenter, Randomized, Placebo-Controlled Study.

作者信息

Zhang Hong, Wang Saiying, Yang Mengchang, Huang Yanjuan, Wang Kai, Jiang Ke, Luo Foquan, Hu Xianwen, Hong Yi, Huang Furong, Jin Shuan, Qi Feng, Wang Shoushi, Zhang Xiaoqing, Luo Huiyu, Guo Langtao, Zhang Longzhen, Li Jiangang, Chen Yongquan, Qin Zhong, Chen Chun, Yang Jianjun, Jiang Wanwei, Fu Nini, Ju Yunfei, Li Yuanyuan, Wang Juan, Ouyang Wen, Feng Yi

机构信息

Department of Anesthesiology, Peking University People's Hospital, Beijing, People's Republic of China.

Department of Anesthesiology, The Third Xiangya Hospital of Central South University, Changsha, People's Republic of China.

出版信息

Drug Des Devel Ther. 2025 Sep 3;19:7707-7718. doi: 10.2147/DDDT.S529526. eCollection 2025.

DOI:10.2147/DDDT.S529526

PMID:40923005

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12414449/

Abstract

BACKGROUND

The dopamine D2/D3 antagonist amisulpride has demonstrated its superiority and efficacy in prophylaxis of postoperative nausea and vomiting (PONV). Given the branded intravenous amisulpride (Barhemsys) has not been approved in China, there is unmet clinical need for amisulpride. Our primary objective was to ascertain the efficacy and safety of the generic intravenous amisulpride (QLG2069) in the prophylaxis of PONV.

METHODS

In this phase III, multicenter, randomized, double-blind, placebo-controlled study, 551 adult Chinese patients (with ≥2 Apfel risk factors for PONV) undergoing elective laparoscopic gynecological or abdominal surgery were randomly allocated in a 1:1 ratio to receive either generic intravenous amisulpride or placebo. The primary endpoint was the complete response (CR) rate, defined as the proportion of patients demonstrating neither emetic episodes (vomiting/retching) nor requiring rescue antiemetics throughout the 24-hour postoperative window.

RESULTS

Totally, 542 patients (amisulpride group: n=275; placebo group: n=267) were included in the full analysis set. Amisulpride demonstrated significantly higher CR rate compared to placebo (53.82% vs 40.07%; P=0.0011) within 24-h postoperative period. Patients treated with intravenous amisulpride exhibited significantly lower incidence of moderate-to-severe nausea (28.36% vs 37.08%; P=0.0266) and emesis (44.73% vs 57.30%; P=0.0030) compared to the incidence in the placebo group. The proportion of patients without nausea was numerically higher (45.09%) in the amisulpride group compared to that in the placebo group (37.45%), although the difference did not reach statistical significance (P=0.0685). No significant difference in the proportions of patients receiving rescue medication was noticed between the two groups (21.09% vs 28.09%; P=0.0569). The incidence of adverse events were comparable in two groups.

CONCLUSION

The generic intravenous amisulpride was safe and effective in prophylaxis of PONV in Chinese patients with moderate-to-high risk of PONV to were undergoing laparoscopic gynecological or abdominal surgery.

摘要

背景

多巴胺D2/D3拮抗剂阿立哌唑已在预防术后恶心和呕吐（PONV）方面显示出其优越性和有效性。鉴于品牌静脉注射阿立哌唑（Barhemsys）在中国尚未获批，临床上对阿立哌唑存在未满足的需求。我们的主要目标是确定通用型静脉注射阿立哌唑（QLG2069）预防PONV的有效性和安全性。

方法

在这项III期、多中心、随机、双盲、安慰剂对照研究中，551例接受择期腹腔镜妇科或腹部手术的成年中国患者（具有≥2个阿佩尔PONV风险因素）以1:1的比例随机分配，接受通用型静脉注射阿立哌唑或安慰剂。主要终点是完全缓解（CR）率，定义为在术后24小时内既无呕吐发作（呕吐/干呕）也不需要使用抢救性止吐药的患者比例。

结果

总共542例患者（阿立哌唑组：n = 275；安慰剂组：n = 267）纳入全分析集。在术后24小时内，阿立哌唑的CR率显著高于安慰剂（53.82%对40.07%；P = 0.0011）。与安慰剂组相比，接受静脉注射阿立哌唑治疗的患者中、重度恶心（28.36%对37.08%；P = 0.0266）和呕吐（44.73%对57.30%；P = 0.0030）的发生率显著降低。阿立哌唑组无恶心患者的比例在数值上高于安慰剂组（45.09%对3�45%），尽管差异未达到统计学意义（P = 0.0685）。两组之间接受抢救药物治疗的患者比例没有显著差异（21.09%对28.09%；P = 0.0569）。两组不良事件的发生率相当。